Low-level Laser and Lifestyle Modifications

NCT05083442 | Completed Results FDA Device

• 1 other identifier: 21-008379
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to evaluate the effectiveness of Low Level Laser Therapy in combination with Lifestyle Modifications in helping people reduce the extra weight and size in the central body region

Conditions

Overweight and Obesity; Weight Loss

Keywords

BMI; Fat Mass; Weight Loss; Body Circumference Reduction

Outcome Measures

Primary Outcomes (2)

• Change in Fat Mass From Baseline to 6 Weeks

  The change in fat mass from baseline to the end of treatments at 6 weeks

  6 weeks

• Change in Waist Circumference From Baseline to 6 Weeks

  The change in waist circumference from baseline to the end of treatments at 6 weeks

  6 weeks

Study Arms (2)

Group 1 - LLLT

ACTIVE COMPARATOR

Subject receive Laser treatments and Lifestyle Modifications

Device: Low Level Laser Therapy

Group 2 - SHAM

SHAM COMPARATOR

Subject receives Sham Laser treatments and Lifestyle Modifications

Other: Sham (placebo)

Interventions

Low Level Laser Therapy DEVICE

Non-surgical cosmetic treatment which can be used by individuals intending to reduce size of the mid-section

Group 1 - LLLT

Sham (placebo) OTHER

Use of sham (placebo) option

Group 2 - SHAM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• have a BMI 25-39.9 kg/m2
• be able to participate fully in all aspects of the study; and
• have understood and signed study informed consent

You may not qualify if:

• have used weight loss medications or participated in a weight loss program within the past 30 days
• are currently taking medications or supplements known to affect weight, such as insulin or sulfonylurea, prednisone or garcinia cambrogia
• have had weight fluctuations of 5 pounds or more in the past month
• have an implanted device (including pacemaker or lap band) in the targeted area of LLLT
• have a known active eating disorder
• have a known, active, untreated clinically significant psychiatric condition (alcohol or substance abuse, psychosis, bipolar disorder, or depression)
• have used an investigational drug within 30 days of study enrollment
• Reports being currently pregnant, lactating, or are of child-bearing potential or are likely to become pregnant during the low-level laser therapy treatment phase and are unwilling to use a reliable form of contraception. Acceptable forms include:
• Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants
• Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)
• Intrauterine device (IUD)
• Total hysterectomy or tubal ligation
• Abstinence (no sex)
• have a history of any major cardiovascular events including heart valve disease, ongoing angina, cardiac arrhythmias, congestive heart failure, acute coronary syndrome, stroke, transient ischemic attack, or peripheral vascular disease
• have current uncontrolled hypertension (systolic \> 160 mm Hg or diastolic \> 95 mm Hg) documented on 2 separate occasions

Sponsors & Collaborators

• Mayo Clinic: lead
• Erchonia Corporation: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Interventions

Low-Level Light Therapy; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Results Point of Contact

• Title: Dr. Ivana Croghan
• Organization: Mayo Clinic Rochester

gimresearchstudies@mayo.edu

507 284-2511

Study Officials

• Ivana T Croghan, PhD

  Professor of Medicine, College of Medicine

  PRINCIPAL INVESTIGATOR

• Ryan T Hurt, MD, PhD

  Mayo Clinic

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomization will be set up by a statistician through REDCap, the data collection system utilized for the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, College of Medicine

Model Details: Randomized clinical trial where subjects are placed into 2 different study arms. Subjects randomized to 2 groups that either receive Low Level Laser therapy with lifestyle modifications or Sham (placebo) with Lifestyle Modifications.

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 19, 2021
• Study Start: June 1, 2022
• Primary Completion: April 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 3, 2025
• Results First Posted: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)